Open Anterograde Radical Prostatectomy Compared to Open Retrograde Technique

NCT02687308 | Completed DMC

• 1 other identifier: 41908815.9.0000.5259
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized study performing open anterograde anatomical radical retropubic prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally invasive techniques were associated with advantages in complications, like intraoperative bleeding, transfusion rates and in earlier recovery of important genitourinary functions such as urinary continence and penile erection. But still has not been demonstrated conclusively advantages as oncological control and it is believed that there are about 200 to 250 cases of learning curve so that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy. These facts associated with the high cost of robotic technology still have limited the generalization of this approach in many developing countries such as Brazil. While the majority of studies made by comparing the radical prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two, there is a significant bias in these studies, which is that the surgical technique used in each procedure differs significantly from minimally invasive and open surgical techniques. The evolution of minimally invasive radical prostatectomy was based on an entirely different anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade way, from bladder neck to the apex, the Walsh RRP technique is completely different in several ways, the dissection is made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with the specimen, and urethrovesical anastomosis, usually performed with multifilament interrupted suture, only for indicating the major differences. The RRP2A will be performed by incision (open surgery) and will be compared with the anatomical radical prostatectomy technique described by Patrick Walsh RRP, and performed by the same surgeons.

Conditions

Prostatic Cancer; Prostatic Neoplasm

Keywords

Prostatic cancer; Radical prostatectomy; Minimally invasive prostate cancer surgery

Outcome Measures

Primary Outcomes (1)

• Surgical time for completed prostatectomy

  Measurement of time for completed surgery. The median operative duration will be measured in minutes and compared between the two techniques

  Day of surgery

Secondary Outcomes (9)

• PSA

  One year

• Time of urinary catheter

  Three months

• Time of urethrovesical anastomosis

  Day of surgery

• Hospital length of stay

  One month

• Positive surgical margins

  Three months

Study Arms (2)

1Retrograde radical prostatectomy RRP

ACTIVE COMPARATOR

This opem surgical prostatectomy techniques described by Patrick Walsh is made through prostatic dissection, from apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture

Procedure: 1 Retrograde radical prostatectomy RRP

2Anterograde radical prostatectomy RRP2A

EXPERIMENTAL

This opem surgical prostatectomy techniques dissect the prostate, bladder neck and the neurovascular bundle, in an antegrade way, from bladder neck to the apex. With careful bladder neck dissection and preservation, careful nervesparing procedures with meticulous retroprostatic dissection of the posterior layer of Denonvilliers' fascia, and urethrovesical anastomosis performed through a monofilament running suture.

Procedure: 2 Anterograde radical prostatectomy RRP2A

Interventions

1 Retrograde radical prostatectomy RRP PROCEDURE

This open surgical technique described by Patrick Walsh involves prostatic dissection made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture

Also known as: Open retrograde radical retropubic prostatectomy (RRP)

1Retrograde radical prostatectomy RRP

2 Anterograde radical prostatectomy RRP2A PROCEDURE

This open surgical techniques performing radical retropubic prostatectomy using the same technique of minimally invasive surgery, antegrade way, from bladder neck to the apex, with careful bladder neck dissection and preservation, incremental or not careful nervesparing procedures and urethrovesical anastomosis performed by monofilament running suture, described by the Pasadena consensus for the procedure assisted by robot.

Also known as: Open anterograde radical retropubic prostatectomy (RRP2A)

2Anterograde radical prostatectomy RRP2A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years or older and willing and able to provide informed consent;
• Histologically and clinically confirmed localized adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
• Surgical indication for open radical prostatectomy;
• PSA less than 20 ng/mL;
• No evidence of metastasis disease;
• Cleared by the primary medical doctor for surgery;
• No prior systemic therapy for prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• Refuses to give informed consent;
• Refuses or is unable to have radical prostatectomy;
• Stage T4;
• Deemed a poor surgical risk per primary medical doctor;
• Received prior therapeutic intervention for prostate cancer;
• Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months;
• Neurogenic bladder;
• Urinary incontinence.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

State University of Rio de Janeiro

Rio de Janeiro, 20551030, Brazil

Location

Related Publications (30)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Fabricio B Carrerette

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: February 22, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study will be alowed when statistical analyses data and results are completed after article is published and estimated time for one year.
• Access Criteria: Men diagnosed with localized prostatic cancer and indication of radical prostatectomy. Exclusion criteria: clinical contra indications for surgery, local advanced prostate cancer and PSA marker up to 20 ng/dL.

Locations

BR (1)